Search results for " process" in Articles / App Notes
Article
Automating the Biomanufacturing Process
As a result, data integration is needed to handle the huge increase in product data from this growth to ensure that these raw data become information that can be used to control and improve the proces…
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Biopharma Says It Has an Evolution in New Technologies and Processes
Technologies such as machine learning, big data, process analytical technology, and automation can assist in the move to performance-based regulation.
FDA has been actively encouraging drug manufa…
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Automating Processes in Upstream Processing
BioPharm: What specific challenges do companies face when automating upstream processes?
Marshall: New product introductions into existing facilities often require new equipment process capabiliti…
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Using Single-Use Technologies in Downstream Processing
While the industry has used SUS in upstream processing for some time now, the use of single-use technologies is becoming popular in downstream processes as well. And it appears that the single-use tre…
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Top challenges in recombinant protein purification process development
I'm really looking forward to this discussion today on recombinant protein purification process development.
In the industry, we're seeing recombinant proteins more often, right? And we're seeing …
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QbD Improves Cell-Culture Process Control
This testing approach typically depends on fixed process conditions and extensive testing of the end product (1). However, using a quality-by-design (QbD) approach that employs predictive modeling can…
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Top Tips for Successful Development of Antibody Chromatography Processes
I'm really looking forward to having a discussion with you about downstream processing and some of the challenges, in terms of producing these therapies.
First and foremost, because no drug …
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Optimizing your Cell Culture Process to Improve Productivity
You can use it to characterize subculture system parameters for process optimizations. Optimal ranges can be determined for various components, and this allows you to keep your cells healthy and produ…
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Tools and Processes for Mature and Emerging Therapies
While technology advances for more traditional biologic-based drugs such as monoclonal antibodies are evolutionary, the processing requirements for emerging cell therapies and gene therapies may requi…
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Efforts Accelerate to Streamline Postapproval Change Process
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine after a drug comes to market to improve products and systems and ensure reliable supply of hig…